• California Passes Breast Density Bill

    September 16, 2011
    by Brendon Nafziger, DOTmed News Associate Editor

    The California State Legislature passed a bill last Friday requiring doctors to inform women if they have dense breasts after a mammogram, making California the second state this summer and the third state so far to have passed a so-called breast density law.

    The bill, SB 791, passed the state Senate 35-1, and is now going before Gov. Jerry Brown to get signed.

    When he signs it, starting next year, Calif. radiologists will have to send women with dense breasts, as determined by an American College of Radiology-developed system, this text:

    Because your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, you might benefit from supplementary screening tests, depending on your individual risk factors. A report of your mammography results, which contains information about your breast density, has been sent to your physician’s office and you should contact your physician if you have any questions or concerns about this notice.

    Texas Gov. and Republican presidential hopeful Rick Perry signed into law a similar bill, Texas Act HB 2102, or Henda’s Law, in June. And breast density legislation was also passed in Connecticut in 2009.

    New Hampshire, Massachusetts, New York and Florida all have similar legislation pending.

    The American College of Radiology Imaging Network says that around 40 percent of women getting screening mammograms have dense breasts, with younger women typically having denser breasts.

    Dense breasts are less fatty, with more connective tissue. The connective tissue appears white on a mammogram, just like the cancer, making it harder to diagnose, according to Are You Dense, an advocacy group.

    A January 2011 study by the Mayo Clinic found three-quarters of cancers in women with dense breasts are missed by mammograms.

    “When it comes to your health, ignorance is not bliss. What you don’t know can hurt you,” State Sen. Joe Simitian, a Democrat from Palo Alto who authored the bill, said in a statement.

    The idea for the bill came from by Amy Colton, a registered nurse who had breast cancer not discovered by a mammogram, and who learned she had dense breasts only after her cancer was diagnosed, according to Are You Dense. She suggested the bill in Simitian’s “There Oughta Be a Law” contest.

    However, the bill met some opposition from the California Medical Association. Writing about an earlier incarnation of the bill, SB 173, the CMA warned that it could bring legal and practical problems for Calif. doctors.

    “Because the scope of who must receive the notice is so broad, women will be ‘scared’ into thinking they need these expensive additional screenings when it isn’t at all warranted, leading to increased costs and pressures on a physician’s practice,” the group wrote in a notice on its website. “Moreover, because the grading of the condition that may/may not lead to their receipt of the prescribed notice is subjective in nature, the absence of the notice could lead to lawsuits against doctors if a patient is later diagnosed with breast cancer.”

    But the bill was backed by several other groups, including the California Nurses Association, the Breast Cancer Fund, the California Association of Health Underwriters and California NOW.

  • California Bill Aimed at Breast Cancer Worries Docs

    SACRAMENTO, Calif. (AP) — It took seven years of annual mammograms and a cancer diagnosis for Amy Colton to learn something her doctors had realized from the beginning: Her breast tissue is so dense that it could have masked tumors on earlier exams.

    “I requested a copy of the report sent from my radiologist to my primary care physician, and every single one said, ‘Patient has extremely dense breast tissue,'” the registered labor and delivery nurse said. “I was really outraged that I didn’t know this.”

    About 40 percent of women over 40 have breast tissue dense enough to mask or mimic cancers on mammograms, but many of them don’t know it. Mammogram providers in California will be required to notify those patients, and suggest that they discuss additional screenings with their doctors based on their individual risk factors, if Gov. Jerry Brown signs a bill that the Legislature passed this month. Similar laws have passed in Texas and Connecticut in the past two years but no data is available yet from either state on the effect of the legislation.

    “The notice in the bill is a two-sentence notice that gets added to a letter,” said the bill’s author, Democratic state Sen. Joe Simitian of Palo Alto. “I believe these two sentences can save thousands of lives.”

    Brown has not given his opinion about the bill, but many doctors oppose it. Researchers studying breast density, a relatively young field, said such requirements may end up causing undo anxiety in millions of women and lead to unnecessary and expensive ultrasound or MRI screenings.

    The California Medical Association, which represents 35,000 doctors, recommended a public education campaign instead of individual notifications, and said there isn’t enough evidence to support the idea the extra money spent on additional screenings will save more lives.

    Those tests could cost the state more than $1 billion, and many women wouldn’t be able to afford them, said Dr. Karen Lindfors, a professor of radiology and chief of breast imaging at the University of California, Davis Medical Center in Sacramento. She testified against the bill before a legislative committee.

    “I just don’t think that at this point we have the ability to meet the kind of demand either financially or in terms of manpower that this is going to create, and we also don’t have proof that it’s going to save lives,” she said.

    The women who would receive the notifications have more tissue than fat in their breasts. As women age, their breasts become more fatty. Fat appears black on a mammogram, making it easier to spot cancer, which shows up as white.

    Doctors agree that high breast density is an increased risk factor for cancer, but researchers say the issue needs more study to determine whether the risk is great enough to justify a higher level of screenings for women who have it.

    Pre-menopausal women are more likely to have dense tissue, regardless of whether they are at high risk for breast cancer, said Celine Vachon, an associate professor of epidemiology at the Mayo Clinic in Rochester, Minn. She said women who get the notifications required by the California bill could be frightened into seeking additional screenings, such as MRIs or ultrasounds, which can pick up false positives and cost thousands of dollars.

    “If women want their breast density information, that’s their right,” Vachon said. “However, breast density is not yet a risk factor that’s used clinically, so what women will do with this information is not clear. We need improved density measurements as well as models that do a better job of predicting women’s risk. Everyone wants density to be this silver bullet, but to date, it’s not.”

    Colton, who got the California legislation rolling by contacting Simitian’s office, said women ought to be told whether their breast density could make cancer difficult to detect.

    She said she practiced self-exams monthly, had no family history of breast cancer and thought she was among the lucky cohort of women at a low risk for breast cancer. But five surgeries, six weeks of daily radiation and 15 rounds of chemotherapy later, she is angered that she went years without being told about her dense breast tissue.

    “I don’t want anyone to think this is a rare story. There are countless women like me, and many with worse diagnoses,” she said.

    Dr. Judy Dean, a diagnostic radiologist in Santa Barbara who specializes in breast imaging, supports the effort. She said 20 of her patients have found cancers through ultrasounds after she informed them that their dense tissue might be hiding tumors in a mammogram.

    “Negative doesn’t mean negative; you could still be positive,” she said.

    All radiologists agree that a mammogram — an X-ray image of the breast — is the best way for a woman to discover whether she has dense tissue, but few agree on how to proceed with that information.

    Researchers have been experimenting with new breast imaging techniques that might provide the same answers as an MRI or ultrasound for women with a high risk for cancer, but with less expense. 3-D X-ray images known as “stereo mammograms” and molecular breast imaging are two techniques that are better than traditional mammograms at spotting cancers and cost much less than MRIs.

    Some say a notice about the hidden risks of dense tissue should be sent to all women receiving the results of their mammogram, not just those with dense tissue. That way, everyone can be armed with the available information, said California state Assemblywoman Linda Halderman, a former breast cancer surgeon.

    She said the bill would end up giving women with low breast tissue density false assurances they are not at risk for cancer.

    “We’re offering something to women that doesn’t help improve their care or shed any light on the best way to assess their risk for breast cancer,” said Halderman, a Republican from Fresno. “Unfortunately, breast density is just one of those things we don’t know about yet.”

  • NHS Breast Screen Program Does Not Give Women Informed Choice, It Misinforms The Public, UK

    Academic Journal
    Main Category: Breast Cancer
    Article Date: 04 Sep 2011 – 9:00 PDT

    Peter C Gøtzsche and Karsten Juhl Jørgensen of the Nordic Cochrane Centre urge for “more honesty” from the NHS BSP (Breast Screening Programme). They believe that harm has been understated, and that information issued to the public has in general been unaffected by “repeated criticism and pivotal research” which has expressed reservations regarding screening benefits and registered considerable over-diagnosis.

    Their paper, “The Breast Screening Programme and Misinforming the Public”, is published in the Journal of the Royal Society of Medicine.

    The authors say:
    “Spokespeople for the Program have stuck to the beliefs about benefit that prevailed 25 years ago and continue to question the issue of over-diagnosis.

    Women therefore cannot make an informed choice whether to participate in screening based on the information the Program provides. This must be changed.”

    The report explains that information is largely embellished, regarding the lives that have been saved through the screening program.

    Professor Peter Gøtzsche, co-author of the paper and Director of the Nordic Cochrane Center, explains:
    “The claim that death rates have fallen ‘in part from earlier diagnosis associated with screening’ is astonishingly misleading.

    Deaths from breast cancer are falling because treatment is improving. There’s been a similar fall in the age-groups not invited to screening. In this respect, and many others, the Program persists in misinforming the public. It was forced to revise its leaflet inviting women for mammography but the new leaflet and their latest Annual Review continue to repeat incorrect mortality estimates.”

    The program estimates that one breast cancer death for every 400 women is prevented by being screened on a regular basis over a ten year period – arguing against this the authors say:
    “(the figure) is wrong by a factor of five. We have been unable to find any evidence for this estimate in reports from the Program or elsewhere. The 1993 meta-analysis of the Swedish trials reported that one breast cancer death was avoided for every 1000 invited women after ten years. The number is 2000 if we use the more realistic estimates of a 15% reduction in breast cancer mortality.”

    They also stress that contradictory information about over-diagnosis is being provided by the NHS BSP.
    “The (2010) Review has reverted to repeating the much too low estimate regarding over-diagnosis from the 2006 Review, but it is obscure as to where this figure comes from. The new leaflet never uses the term over-diagnosis, and although it talks a lot about ‘benefits’ it does not use the equivalent term ‘harms’ but just speaks about ‘downsides’, which is far less negative.”

    In the report they explain that “the only hint at over-diagnosis” in the invitation leaflet is the sentence ‘Screening can find cancers which are treated but which may not otherwise have been found during your lifetime’. They believed this is vague and readers may understand that screening can only be good, as it detects cancers which would otherwise be hard to find.

    The researchers tried out the sentence on a group of fourth year medical students – by this time in their training they still would now have had lectures about screening. They discovered almost half did not understand the sentence and one third believed it was bad for women to have these cancers detected.

    The researchers said:
    “There is no quantification of over-diagnosis in the leaflet and no estimate of the balance between benefit and harm.”

    The Programs 2010 Annual Review was criticized by the authors for using sentences, such as..:
    “If a breast cancer is found early, you are less likely
    to have a mastectomy.”

    ..claiming that the program encouraged belief that screening will reduce the chances of the women needing to have a mastectomy. The authors express:
    “But such claims are seriously misleading. Danish data has demonstrated that because of over-diagnosis, screening increases the use of mastectomies substantially.”

    Written by Grace Rattue